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Circulation. 2018 May 22;137(21):2246-2253. doi: 10.1161/CIRCULATIONAHA.117.029375. Epub 2018 Feb 1.

Transplant-Free Survival and Interventions at 6 Years in the SVR Trial.

Author information

1
Boston Children's Hospital and Harvard Medical School, MA (J.W.N., L.A.S., C.D.-M.). jane.newburger@cardio.chboston.org.
2
Boston Children's Hospital and Harvard Medical School, MA (J.W.N., L.A.S., C.D.-M.).
3
Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
4
New England Research Institutes, Watertown, MA (D.H.-P., S.C., P.S.).
5
Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F., N.S.G.).
6
North Carolina Consortium, Duke University, Durham (J.S.L.).
7
East Carolina University, Greenville, NC (J.S.L.).
8
Wake Forest University, Winston-Salem, NC (J.S.L.).
9
Children's Healthcare of Atlanta and Emory University, GA (W.T.M.).
10
Morgan Stanley Children's Hospital of New York-Presbyterian, Columbia College of Physicians and Surgeons, NY (I.A.W.).
11
Medical University of South Carolina, Charleston (A.M.A.).
12
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (KM.B.).
13
Cincinnati Children's Medical Center, OH (J.C.).
14
University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.).
15
Congenital Heart Institute of Florida, St. Petersburg (J.P.J.).
16
Children's Hospital Los Angeles, CA (A.B.L.).
17
Hospital for Sick Children, Toronto, Ontario, Canada (S.M.).
18
Nemours Cardiac Center, Wilmington, DE (C.P.).
19
Primary Children's Hospital and the University of Utah, Salt Lake City (A.E.).

Abstract

BACKGROUND:

In the SVR trial (Single Ventricle Reconstruction), 1-year transplant-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt (RVPAS) compared with a modified Blalock-Taussig shunt in patients with hypoplastic left heart and related syndromes. At 6 years, we compared transplant-free survival and other outcomes between the groups.

METHODS:

Medical history was collected annually using medical record review, telephone interviews, and the death index. The cohort included 549 patients randomized and treated in the SVR trial.

RESULTS:

Transplant-free survival for the RVPAS versus modified Blalock-Taussig shunt groups did not differ at 6 years (64% versus 59%, P=0.25) or with all available follow-up of 7.1±1.6 years (log-rank P=0.13). The RVPAS versus modified Blalock-Taussig shunt treatment effect had nonproportional hazards (P=0.009); the hazard ratio (HR) for death or transplant favored the RVPAS before stage II surgery (HR, 0.66; 95% confidence interval, 0.48-0.92). The effect of shunt type on death or transplant was not statistically significant between stage II to Fontan surgery (HR, 1.36; 95% confidence interval, 0.86-2.17; P=0.17) or after the Fontan procedure (HR, 0.76; 95% confidence interval, 0.33-1.74; P=0.52). By 6 years, patients with RVPAS had a higher incidence of catheter interventions (0.38 versus 0.23/patient-year, P<0.001), primarily because of more interventions between the stage II and Fontan procedures (HR, 1.72; 95% confidence interval, 1.00-3.03). Complications did not differ by shunt type; by 6 years, 1 in 5 patients had had a thrombotic event, and 1 in 6 had had seizures.

CONCLUSIONS:

By 6 years, the hazards of death or transplant and catheter interventions were not different between the RVPAS versus modified Blalock-Taussig shunt groups. Children assigned to the RVPAS group had 5% higher transplant-free survival, but the difference did not reach statistical significance, and they required more catheter interventions. Both treatment groups have accrued important complications.

CLINICAL TRIAL REGISTRATION:

URL: https://www.clinicaltrials.gov. Unique identifier: NCT00115934.

KEYWORDS:

Norwood procedure; cardiac surgery; congenital heart defect; congenital heart disease; single ventricle

PMID:
29437119
PMCID:
PMC5963989
DOI:
10.1161/CIRCULATIONAHA.117.029375
[Indexed for MEDLINE]
Free PMC Article

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